Recall Z-2685-2011 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
Beckman Coulter UniCel DxI 800 Access Immunoassay System with Unicel DXI system software version 4.3
| Date | Jun 28, 2011 (initiated Jul 6, 2010) |
| Status | Terminated |
| Reason | Test results may have incorrect ranges. If a default sample type setting on the tests screen is changed while running Unicel DXI system software version 4.3, the new setting is not saved to the system database. The changed sample type setting will reset to the previously saved setting when power is interrupted to the system, or if an operator reboots the system. If the default sample type i |
| Root cause | Software design |
| Action | Beckman Coulter forwarded on 7/6/10 a Product Corrective Action letter with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the UniCel Dxl 600 and Dxl 800 Access Immunoassay systems. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to: A revised version of UniCel DxI System Software that corrects this issue is currently in development. Until the new software version is available, Beckman Coulter has provided an alternate method for changing the default samp |
| Quantity | 626 units |
| Distribution | Nationwide in the US and to Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023764 | UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 Beckman Coulter, Inc., Jan 28, 2003 |